7.  The applicants were born in 1977, 1954, 1948, 1947, 1948, 1973, 1948, 1966, 1935 and 1947 respectively, and live(d) in Plovdiv, Godech, Dobrich, Kazanlak, Plovdiv, Ruse, Samokov and Sofia respectively.
8.  The first applicant in application no. 47039/11 and all eight applicants in application no. 358/12 have or had various types of terminal cancer. The second applicant in application no. 47039/11 is the first applicant’s mother. Four of them succumbed to the illness shortly after lodging their applications (see paragraph 4 above).
9.  Having either tried a host of conventional treatments (including surgery, chemotherapy, radiotherapy and hormone therapy), or obtained a medical opinion that such forms of treatment would not work in their respective cases or were not available in Bulgaria, all of them approached a private clinic in Sofia, the Medical Centre for Integrative Medicine OOD (Медицински център Интегративна Медицина ООД), where they were told about an experimental anti-cancer product (MBVax Coley Fluid) which was being developed by a Canadian company, MBVax Bioscience Inc. According to information from that company, their product has not been authorised in any country, but has been allowed for “compassionate use” (for a definition of that term and comparable terms, see paragraphs 50, 56 and 57 below) in a number of countries (the Bahamas, China, Germany, Ireland, Israel, Mexico, Paraguay, South Africa, Switzerland, the United Kingdom, and the United States of America). In a letter of 9 January 2011 to the Bulgarian Ministry of Health, the company said that as part of its pre‑clinical development of the product it would be willing to provide the product free of charge to the Medical Centre for Integrative Medicine OOD, for use on cancer patients who could no longer benefit from conventional treatments, in return for data on the treatment’s adverse and beneficial effects on each patient. It appears that the Medical Centre for Integrative Medicine OOD has on a number of occasions in the past few years applied for permission to import and use the product, but to no avail.
10.  The parties were in dispute as to whether MBVax Coley Fluid had recently started undergoing clinical trials. The applicants said that, according to data extracted on 18 April 2012 from the website of the United States National Cancer Institute and a website maintained by the United States National Library of Medicine, Mixed Bacteria Vaccine (MBV) was undergoing a phase one clinical trial in Germany. On that basis, they argued that it complied with the requirements of Article 83 § 2 of Regulation (EC) no. 726/2004 (see paragraph 50 below). The Government disputed that assertion, and submitted that it was not acceptable to establish the existence of clinical trials in Germany through information from websites in the United States of America.
11.  The Government further submitted that MBVax Coley Fluid could not be described as a medicinal product within the meaning of the applicable European Union and domestic provisions. The applicants replied that the fact that it had not been authorised did not mean that it was not a medicinal product within the meaning of those provisions.
12.  According to the applicants, MBVax Coley Fluid has been used with some success on patients in clinics in Germany, Ireland, the United Kingdom, and the United States of America. In support of that assertion the applicants submitted a number of letters and electronic mail messages from medical practitioners.
13.  It appears that on 23 July 2011 one of the applicants, Mr Petrov, travelled to Germany, where he obtained the product from MBVax Bioscience Inc. free of charge and it was administered to him seven times. However, shortly afterwards he returned to Bulgaria because he could no longer afford to pay his living expenses in Germany or the fees of the health-care institution which administered the treatment.
14.  Each of the applicants, including Ms Staykova‑Petermann, who was acting on behalf of her sick son – applied to the authorities for permission to use MBVax Coley Fluid. In letters of 20 June, 15 July and 1 and 31 August 2011 the Director of the Medicines Executive Agency (Изпълнителна агенция по лекарствата), the authority in charge of supervising the quality, safety and efficacy of medicinal products, pointed out that MBVax Coley Fluid was an experimental product not yet authorised or undergoing clinical trials in any country, which meant that it could not be authorised for use in Bulgaria under Regulations no. 2 of 2001 (see paragraphs 25 and 26 below). He went on to say that Bulgarian law made no provision for the use of unauthorised medicines outside clinical trials, and that, unlike the situation obtaining in other European countries, in Bulgaria compassionate use of unauthorised products was not possible. Under the law of the European Union there was no obligation to have a harmonised approach in this area. In some of the letters the Director added, without going into detail, that the information the applicants had about MBVax Coley Fluid was incorrect.
15.  Some of the applicants appealed to the Minister of Health, who in a letter of 13 July 2011 fully agreed with the position expressed by the Medicines Executive Agency.
16.  Three of the applicants in application no. 358/12 applied to the Ombudsman of the Republic. By letters of 22 July and 4 and 14 September 2011 the Ombudsman also informed them that MBVax Coley Fluid had not been authorised in any country, which meant that the only way in which they could obtain access to it in Bulgaria was as part of a clinical trial.
17.  The applicants did not seek judicial review.
18.  On 27 October 2011 the Sofia Regional Health Directorate decided to strike the Medical Centre for Integrative Medicine OOD out of the register of health institutions, on the ground that it was engaging in activities in breach of established medical standards. The clinic sought judicial review of the decision in the Sofia Administrative Court. A hearing was held on 8 December 2011. A second hearing was listed for 24 February 2012, but was adjourned to 14 June, then to 5 October, and then to 12 October 2012. The case is still pending before the Sofia Administrative Court.